Cleared Traditional

SEROFAST

K903958 · Intl. Mycoplasma/Mdc Assoc. · Microbiology

Dec 1990

Decision

115d

Days

Class 1

Risk

About This 510(k) Submission

K903958 is an FDA 510(k) clearance for the SEROFAST, a Antisera, All Mycoplasma Spp. (Class I — General Controls, product code GSA), submitted by Intl. Mycoplasma/Mdc Assoc. (Manchester, US). The FDA issued a Cleared decision on December 21, 1990, 115 days after receiving the submission on August 28, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3375.

Submission Details

510(k) Number	K903958 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 1990
Decision Date	December 21, 1990
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—